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Shire plc: Excellent Performance Across All Areas of the Business and Accelerating New Product Sales Drive Revenue Growth of 36%
Date:2/21/2008

able foreign exchange rate movements.

Other

Other royalties are primarily in respect of REMINYL and REMINYL XL (known as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide (excluding the UK and the Republic of Ireland) by Janssen Pharmaceutical N.V. ("Janssen"), an affiliate of Johnson & Johnson. Shire has the exclusive marketing rights in the UK and the Republic of Ireland.

Barr and other companies have filed ANDA with the FDA for generic versions of RAZADYNE. Janssen and Synaptech Inc. ("Synaptech") have filed lawsuits against some of those ANDA filers. A trial was held during the week of May 21, 2007. No decision from the court has been issued to date.

Janssen and Synaptech filed lawsuits against Barr and Sandoz Inc. ("Sandoz") for infringement of their patent rights relating to RAZADYNE ER as a result of Barr and Sandoz filing ANDAs with the FDA for generic versions of RAZADYNE ER. No court dates have been set.

4. Financial details Cost of product sales

For the year to December 31, 2007 the cost of product sales was 14% of product sales (2006: 16%). The cost of product sales for REPLAGAL in 2006 included a $47.0 million (3% of product sales) adjustment in respect of inventories acquired through the acquisition of TKT. Excluding the impact of this fair value adjustment, cost of product sales as a percentage of product sales in 2006 was 13%. The increase in cost of product sales as a percentage of products sales in 2007 over 2006 was primarily due to a shift in product mix resulting from increased sales of launched products, which had lower margins than existing products, and the write-off of inventory following the voluntary market withdrawal of a limited quantity of DAYTRANA patches.

For the year to December 31, 2007 cost of product sales included a charge of $5.5 million for share based compensation (2006: $3.2 million) which included a $2.1 million cumulative catch up charge in respect of t
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SOURCE Shire plc
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